This Funding Opportunity Announcement (FOA) invites
applications from qualified institutions for support of Environmental Health
Sciences Core Centers (EHS CC). An EHS CC is designed to establish leadership
and support for programs of excellence in environmental health sciences by
providing scientific guidance, technology, and career development
opportunities for promising investigators. A Core Center Grant is an
institutional award to support centralized scientific resources and
facilities shared by investigators with existing research projects. By
providing structure and resources, this support is intended to enhance the
ability of scientists working in the field of environmental health sciences
to identify and capitalize on emerging opportunities that will translate into
advances improving the understanding of the relationships among environmental
exposures, human biology, and disease.

Key Dates

Posted Date

December 20, 2013

Open Date (Earliest Submission Date)

March 22, 2014

Letter of Intent Due Date(s)

March 22, 2014

Application Due Date(s)

April 22, 2014, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2014

Advisory Council Review

January 2015

Earliest Start Date

April 1, 2015

Expiration Date

April 23, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically; paper applications
will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently
used with most NIH opportunities and provides many features to enable
electronic multi-project application submission and improve data quality,
including: pre-population of organization and PD/PI data, pre-submission
validation of many agency business rules and the generation of data summaries
in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts)
and where instructions in the Application Guide are directly related to the
Grants.gov downloadable forms currently used with most NIH opportunities.
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The overall goal of the Environmental Health Sciences Core
Center (EHS CC) enhances the capabilities of existing programs in environmental
health sciences, assists with building programmatic and scientific capacity, leads
in development of novel research directions, recruits and grooms future leaders
in the field, and pioneers efforts in community engagement. The EHS CC must be
an identifiable organizational unit within a single university, medical center,
or a consortium of cooperating institutions with a university affiliation. The
EHS CC grant provides core support to accelerate and deepen the insights into
research along the spectrum from basic science findings to population and
public health and dissemination. The NIEHS approach is for this mechanism to foster
integration, coordination, and translational cooperation among investigators
conducting high-quality research clearly related to the effects of
environmental factors on human health, to integrate and build upon existing
programs in order to answer complex questions leading to improved strategies
towards preventing environmentally-induced disorders and interacting
bi-directionally with affected communities. While the EHS CC grant provides
support for core resources and facilities, it does not provide direct funding
for research projects, although limited funds are provided for pilot projects.

To qualify for a EHS CC, the applicant institution must
already have a substantial base of ongoing, independently supported,
peer-reviewed research projects clearly dedicated to the study of environmental
health sciences or environmental medicine, a substantial portion of which
should be supported by NIEHS. This currently funded research base provides the
major support for a group of investigators who would benefit from shared
resources. The research base must exist prior to the submission of an
application and will be considered by program staff. Focus, relevance,
interrelationships, quality, productivity, and, to some extent, quantity, are
all considerations in judging the adequacy of the research base.

In order to provide increased flexibility in organization
and structure of the EHS CC, the Director may develop a dynamic structure which
meets the on-going intellectual needs of the members. This structure can
change as the intellectual needs change to accommodate new opportunities for
collaboration. Research Cores are not required as organizational units but are
allowed.

NIEHS considers community engagement to be a major goal of
the EHS CC and a Community Outreach and Engagement Core is required.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

NIEHS intends to fund an estimate of 4 - 6 awards,
corresponding to a total of $7.5M, for fiscal year 2015. Future year amounts
will depend on annual appropriations.

Award Budget

Application budgets are limited to $1.3M Direct Costs per
year.

Award Project Period

The project period is limited to 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Only one application per institution (normally identified by
having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants can access the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and
submitted using applicant systems capable of submitting electronic
multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Additional page limits described in the SF424 Application
Guide and the Table of Page
Limits must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall: required

Administrative Core: required

Integrated Health Sciences Facility Core (IHSFC): required

Community Outreach and Engagement Core (COEC): required

Facilities Core: at least one required

Pilot Project Program: required

Career Development Core: required

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components
should be repeated in cell line table in Overall component.

Research & Related Other Project
Information (Overall)

Follow standard instructions.

Project
Summary/Abstract. Provide a Project Summary/Abstract of a
Strategic Vision for the Center. Also describe the Environmental Health
Identity and the Impact of the Research Base on the goals of the EHS CC.

The application must indicate a minimum of three
distinct active NIEHS-supported research grants from three-member PDs/PIs with
at least 1 full year of activity remaining at the time of submission, not
including administrative extensions, either with or without additional funds.

Project
Narrative. In the project narrative (i.e., the "public
health relevance" statement), briefly state the relevance of the Center’s
research to public health.

Facilities
and Other Resources: Describe the Institutional Commitment for
the proposed EHS CC at the applicant institution. Document previous and
planned institutional support: e.g., financial, personnel, positions, and/or
priority access to resources. Also describe the organizational position of the
EHS CC in the institutional hierarchy.

Address the commitment of the parent organization or
any of its partners to the EHS CC and its goals. The parent institution is
expected to recognize the EHS CC as a formal organizational component and
provide documented evidence of space dedicated to the needs of the Center,
protected time to devote to Center activities, staff recruitment, dedicated
equipment, or other financial support for the proposed Center. The parent
institution should provide assurance of its commitment to continuing support of
the EHS Core Center in the event of a change in directorship and a well-defined
plan for this eventuality should be in place. In addition, it is expected that
the Institution will support the goal of providing to Center members’ priority
access to Institution’s and Center’s facilities and services at minimal or
reduced cost.

Other
Attachments. The following "Other Attachments" should
be included with the overall component in order to aid in the review of
applications. The filename provided for each attachment will be the name used
for the bookmark in the application image.

Grant
Support - Please title this attachment "Grant Support" and include
all Federal and non-federal grant support for EHS CC members. Include Grant
numbers, levels of effort for the PD/PI, complete title, EHS CC collaborators,
annual direct costs, and the funding period. List NIEHS – supported grants first
in the list. Table A1 and Table A2 are provided for applicant assistance with
this requirement (see http://www.niehs.nih.gov/research/supported/dert/programs/core/guidelines/index.cfm).

Applicants may prepare their own Tables or formats in
place of Tables A - E, but all Tables should be converted to pdf for uploading.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A
summary of Project/Performance Sites in the Overall section of the assembled
application image in eRA Commons compiled from data collected in the other
components will be generated upon submission.

Research & Related Senior/Key
Person Profile (Overall)

Include only the Project Director/Principal
Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the
entire application.

A
summary of Senior/Key Persons followed by their Biographical Sketches in the
Overall section of the assembled application image in eRA Commons will be
generated upon submission.

Budget (Overall)

The only budget information included in the Overall
component is the Estimated Project Funding section of the SF424 (R&R)
Cover.

A
budget summary in the Overall section of the assembled application image in eRA
Commons compiled from detailed budget data collected in the other components
will be generated upon submission.

PHS 398 Research Plan
(Overall)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is required in the Overall component.

Specific
Aims: A strategic vision, theme, and set of goals must be
developed and described in the application. The Center Director must provide a
written strategy for how the EHS CC will implement this vision and which future
directions will likely be followed during the project period. The plan will
outline the existing skills, technologies and scientific research base and
other resources at an institution. This plan should describe how the Core
Center will enhance ongoing projects, assist in the introduction of outstanding
new projects, respond to future challenges and opportunities, and promote
collaborations, advances in technology, and progress in environmental health
sciences. The Center Director must detail expected scientific outcomes
including a description of anticipated impact on human disease and public
health. An organizational chart should be included to illustrate the
structure, interactions, and leaders of the EHS CC.

Research
Strategy: The Strategic Vision must address the following
critical elements:

Theme – Provide the central theme(s) of the EHS CC
and the likely supported research, resources, and relevance to environmental health.
The theme may be broad or focused, depending upon the goals of the EHS CC but
should indicate translational elements along the spectrum from laboratory
research to public health, disease prevention, and community engagement. Within
this section, describe the research capacity and clearly identifiable major
scientific focus in environmental health and related biomedical research. Include
identification of target communities and steps or plans to engage them. The EHS
CC grant mechanism fosters interdisciplinary cooperation among established investigators
conducting high-quality research in environmental health science. Therefore,
existence of a strong research capability in environmental health sciences is
fundamental to establishment of a new, or continuation of an existing, EHS CC.

Goals and directions – Describe current and future
directions for the EHS CC in the forthcoming project period. The impact of
Center-based science should be discussed in detail.

Provide an overview of the research supported by the EHS
CC and its likely impact on the understanding of environmental health sciences
and, ultimately, public health. Describe how the central themes and goals
integrate with the needs and concerns of the target communities. Describe short
and long-term goals and measures of success. Provide expected likely advances
in the field of environmental health and the impact these advances will likely
have on disease and public health. Describe basic science work of the Center
members or teams that has successfully been translated to the bedside or
community or plans to translate it in the project period. Describe expected,
widely-applicable research tools that will emerge from the Center’s emphasis.
Document how the Center forms, organizes, and leads its teams towards answering
complex questions and the role of target communities or community advisors in
these decisions. Identify levels of risk for these goals, potential roadblocks
to achieving them, and how the Center might respond to these challenges. Applications
might also describe the earlier accomplishments of the Center teams - either
funded or not by NIEHS - and how it intends to build upon its successes. These
accomplishments should be presented, as appropriate in the areas of basic
science, clinical research, public health, disease prevention, and community
engagement. Plans for COEC must indicate how this entity will integrate with
the EHS CC, interact with target audiences, and promote the vision of the
Center.

Integration of investigators of multiple skills and
talents – Outline steps the EHS CC will take to promote interdisciplinary
studies and collaborations, especially among basic scientists and clinical
researchers, and, where appropriate, community engagement experts. Explain the
types of initiatives planned to stimulate teams and attract high-caliber
professionals. Describe the expected level of high-risk/high-payoff research
that may require long-term support.

Building research capacity – Provide details on the
special talents and resources that will be drawn to and built upon at the EHS
CC. Offer how these talents will be harnessed to promote new collaborations and
produce multidimensional teams to address complex questions. Include a plan
for bringing investigators into the EHS CC from within and outside the area of
environmental health sciences and needed expertise. Describe academic and
research partnerships that will be pursued by the EHS CC to advance its goals
and missions. Provide a plan to determine the need for services and
instrumentation of the EHS CC. Address the steps that will ensure that the EHS
CC proceeds at the cutting edge of technology and concepts. As it is expected
that facility core needs will change over time, include the process to evaluate
needs and implement changes.

The application must define, in this section, the
eligibility criteria for EHS CC membership and note which individuals play key
leadership roles in the EHS CC. Indicate the steps to engage full and/or
junior members in EHS CC activities and to enhance collaborations and translational
research among Center members. Describe how established
investigators/community engagement experts will be engaged as advisors or
mentors for early stage career Center members.

Steps taken to encourage research and/or Outreach
Teams that focus complementary expertise on complex and emerging questions in
environmental health should be discussed within the Strategic Vision. Steps
taken to encourage such activities and brief examples of ongoing or planned
research should be discussed as appropriate with reference to supporting
Facility Cores. Do not provide an exhaustive list of ongoing incremental
research. Weave significant findings and advances throughout the narrative of
this section to demonstrate the leadership and impact of the center on building
its environmental health sciences program.

For renewals, summarize activities carried out during
the preceding performance period that demonstrate the level of success in
reaching previously stated goals.

Environmental Health Identity and Impact of Research
Base - The EHS CC fosters interdisciplinary cooperation among established
investigators conducting high-quality research in environmental health science.
Therefore, existence of a strong research capability in environmental health
sciences is fundamental to establishment or continuation of a EHS CC. To
qualify for support, an institution must demonstrate this research capability
so as to have a clearly identifiable, major scientific focus in environmental
health research. Consequently, an existing program of excellence in biomedical
research in the field of environmental health science is a basic prerequisite
for establishment of a EHS CC and it must demonstrate it can capitalize upon
these research capabilities and resources to significantly advance
understanding of its chosen scientific focus. Please describe the
Environmental Health Identity and Impact of the Research Base on the plans for
promoting translational research and outreach efforts.

To successfully compete for funding, the membership
at the applicant institution or consortium must have a minimum of three active
NIEHS-supported research grants from three distinct PDs/PIs. At the time of
submission of a competing application, the qualifying grants must have at least
1 full active year remaining not including administrative extensions, either
with or without additional funds. Acceptable grant support includes R01, R03, R21,
R37, P01, P42, P50, Cooperative Agreements (U-grants) or Research Career
Development Awards (K-grants). Conference awards (R13, U13) are not acceptable.
Each multi-component (e.g. P01, P50, or U01) award will count as one qualifying
research project regardless of the location of the parent grant.

Research grant support from NIH and sources other
than PHS should be listed and will be considered in the determination of its
suitability of focus on environmental health sciences if the research is (1)
related to human health in areas where there is evidence for the involvement of
environmental factors in disease etiology or phenotypic expression, (2) of
outstanding quality, and (3) funded based on peer or internal review of rigor
comparable to that of PHS.

NIEHS will make the final decision in determining
whether the applicant EHS CC Institution has the critical mass of grants,
investigators, and projects in the area of environmental health. Prior to
submission of an application, the proposed Center Director is encouraged to
consult with Institute Staff regarding the adequacy of the research base.

Letters
of Support: Letters of support should be provided where
appropriate to demonstrate collaboration, access to resources, institutional
commitment, etc.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Administrative Core)

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in
the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key people that are working
in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

The Center Director is expected to be of appropriate
experience with authority to oversee the organization and operation of the EHS
CC and to provide scientific and administrative leadership for the total
program. The Center Director should devote at least 2.4 months annual effort to
the EHS CC. A Deputy Center Director must also be designated to serve in the
absence of the Director.

Budget (Administrative Core)

Budget forms appropriate for the specific component
will be included in the application package.

Allowable
Budget for the EHS CC

Allowable Direct Costs are based on the Direct Costs
of NIH grants led as PD/PI by EHS CC members. The sum of qualifying NIEHS
support (as defined below) plus 0.1 multiplied by other qualifying NIH funded
grants are used to find the maximum allowable Direct Cost of an application.

For applications competing for FY2015 funding, the allowable
Direct Cost level is determined by Table 1.

=============================================

Table
1

--------

Qualifying NIH Support Allowable

[NIEHS + 0.1 (other NIH)] Direct
Costs

----------------------------------- --------------

Up to and including $3,000,000 $ 700,000

$3,000,001 - $10,000,000 $1,000,000

Above $10,000,000 $1,300,000

=============================================

In the following example, if an Institution's
membership includes PDs/PIs on NIEHS grants with Direct Costs totaling $2.0M
and other NIH grants with Direct Costs totaling $6M, the maximal allowable
budget would be $700,000 as calculated, below:

Qualifying Support = [$2.0M + 0.1($6M) ] = $2.0M +
$0.6M = $2.6M

The calculated value of Qualifying Support is less
than $3M and, according to Table 1, allows a request of $700,000 Direct Costs.

Budgets are limited to $1.3M Direct Costs in any one
year.

Qualifying
Grants and Cooperative Agreements:

i. All qualifying support must have at least 1
active year remaining at the time of submission and be clearly focused on
environmental health science.

ii. NIEHS: K-awards, P01, P42, R01, R03, R21, R37,
U01, U19

iii. Other NIH Institutes: K-awards, P01, R01, R03,
R21, R37, U01

iv. In the case of multicomponent projects such as
P01 or P42 only costs of the sub-project led by the EHS CC member may be
included.

v. Not included, regardless of institute: R43, R44,
T-awards, U45, clinical trials, grants and cooperative agreements in extension
periods, either with or without additional funds, supplements of any kind.

NIEHS Program Staff will make the final determination
on whether a grant qualifies for inclusion in budget calculations. All grants,
in particular those supported by non-NIEHS Institutes, must clearly focus on
Environmental Health Science.

Other
Budget Information

At a minimum, the greater of $80,000 Direct Costs or 10%
of the total direct costs are to be devoted annually to COEC.

In
non-competing years, EHS CC with Direct Costs of less than $1M may re-calculate
the budget and request an additional $50,000 direct costs by demonstrating a
significant increase of NIEHS - support. Increases in the award will be based
on determination by NIEHS Program Staff and availability of funds.

All
travel associated with the annual EHS CC Meeting or External Advisory Board
members should be budgeted within the Administrative Core.

COEC is to budget travel for its field or community
work, etc. within that section.

Annual EHS CC Meetings: Each Center must budget
$5,000 per year to support the annual EHS CC Meetings in venues to be
determined in collaboration with the Center Investigators and NIEHS. Travel
costs should also budget for EHS CC members to travel to the annual 2 - 3 day
meeting at a minimum for the Director, COEC Director, and Administrative
Assistant. EHS CC should expect to host such a meeting once within the project
period and may want to set funds aside for the event. Please consult with
program staff for details.

Items
Not Allowed Under a P30 EHS CC Grant Include:

1. Direct support of individual research except for
Pilot Projects.

2. Salary for Co-Directors, Co-investigators, or
individuals unless clearly defined roles are documented in the operation of the
EHS CC.

3. Travel to workshops or scientific meetings, other
than training in the course of Career Development activities.

4. Page and publication charges.

5. Director’s Funds or Discretionary Fund.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Administrative
Core)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims: State the aims of the Administrative Core.

Research
Strategy: This component oversees organizational, budgeting and
reporting aspects and provides the leadership for scientific and programmatic
activities of the EHS CC. Include in this section a description of the Center
Director and Deputy Director. The application must name the Center Director who
will serve as the PD/PI of the Center and Core Leader of the Administrative
Core.

Through the required Administrative Core, the Center
Director provides leadership and guidance in fulfilling the stated objective of
his or her Center. To accomplish this, the applicant must create within
the Administrative Core an infrastructure that promotes cross-discipline
interactions among all of the projects and cores and ensures research translation.
The structure of this core will provide the Center Director with a mechanism
for planning and coordinating research and core activities; integrating
cross-discipline research; overseeing fiscal and resource management; and
quality management.

The Center Director is expected to be of appropriate
experience with authority to oversee the organization and operation of the EHS
CC and to provide scientific and administrative leadership for the total
program. A Deputy Center Director must also be designated to serve in the
absence of the Director, with other responsibilities described. The background
and scientific and administrative expertise and responsibilities of the Center
Director and the Deputy Director should be described fully in the application.
It is expected that the Center Director, as well as the Deputy Center Director,
will have considerable experience as a leader in environmental health sciences
and distinguished records of scientific and administrative accomplishment. Summarize
examples of administrative and scientific leadership carried out during earlier
performance periods. If applicable, cite accomplishments of the Director and
Deputy Director as heads of academic departments, multi-component research
programs, or center entities.

The Deputy Director is expected to play an active
role in the organization and operation of the EHS CC. The roles and authorities
are left to the team to develop, but potential responsibilities include
oversight of Career Development, Pilot Projects, one or more Research Core
activities, or other Leadership activities.

It is expected that leadership will transition within
a reasonable period. Please briefly describe plans for a succession plan for EHS
CC leadership to maintain the entity at the pinnacle of the field, either
temporarily or permanently.

The application should describe how the
Administrative Core will take a leadership role in ensuring the synthesis of
findings and activities from research projects and cores towards solving the
central problem proposed by the Center. In addition, direct lines of
communication between the Administrative Core and Community Outreach and
Engagement Cores (as well as with the other cores, as appropriate) should be
delineated, as all of these cores serve critical roles for Center integration.

It is expected that organization of the
Administrative Core will provide a supportive structure sufficient to ensure
accomplishment of the following:

Coordination
and integration of EHS CC components and activities.

Assessment
of productivity, effectiveness, and appropriateness of EHS CC activities and
determination of EHS CC membership assessment of scientific opportunities and
areas for collaboration among EHS CC members.

Organization
of EHS CC activities, such as retreats, invitation of consultants, meetings,
and focus groups.

Organization
of the Internal and External Advisory Groups.

Recordkeeping
of meeting minutes and measures of success including: use of EHS CC facilities,
publications, pilot project awards, and new grant applications resulting from
preliminary data enabled by the EHS CC.

Interactions
with other EHS CCs, the NIEHS, and other appropriate individuals, groups, or
organizations.

The administrative structure must include an Internal
Advisory Committee (IAC) and an External Advisory Committee (EAC). Renewal
applications must document the functions and effectiveness of the External and
Internal Advisory Committees. Do not list potential EAC members in the
application.

Letters
of Support: Include letters of support where appropriate to
demonstrate collaborations, access to resources, institutional commitment, etc.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Integrative Health Sciences Facility Core

When preparing your application in ASSIST, use Component
Type 'Core.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in
the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

Budget (Integrative Health Sciences
Facility Core)

Budget forms appropriate for the specific component
will be included in the application package.

For a list of allowed or restricted budget items,
please see the Budget section under Administrative Core above.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Integrative
Health Sciences Facility Core)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims: State the aims for the Integrative Health Sciences
Facility Core (IHSFC). The IHSFC is required and should be designed to
facilitate translational research findings bi-directionally along the spectrum
from basic and/or clinical research to the applied or public health arenas.
This Core provides new and critical resources that will be a vital component of
the progression of environmental health sciences from the laboratory to
affected communities and public health. It is expected that the concepts and
goals of environmental health will be integrated into the range of activities
that the greater EHS CC undertakes.

Research
Strategy: The IHSFC Core is to be designed to support
collaborative efforts among basic scientists, clinical researchers, community
engagement experts, and/or public health practitioners by:

Providing
services and access to instrumentation and technologies that foster integration
of basic science, public health research including epidemiology and
intervention studies, and patient-oriented clinical research.

Supporting
research to improve early detection, prevention, and/or therapeutic strategies
for environmentally–related disorders.

Enhancing
partnerships between researchers and community-based organizations that impact
on conduct of clinical and public health research.

Among its functions, the IHSFC may provide services
that capitalize on access to well-characterized patient groups and control
subjects for research projects. These can include study subject recruitment and
retention activities, and follow-up by mail, phone or in-person to gather
needed data for research projects. Clinical services may include clinical
laboratory or other assessments, pathology services, collection, processing and
long-term storage of human tissue samples, blood, urine or other biospecimens,
and preparation of questionnaires or other assessment tools. Among its roles, the
IHSFC can facilitate and support partnerships between study investigators and
human populations, communities, or health care providers. Description of
services, equipment, and other activities of this core need to be well
documented. When applicable, procedures for collecting, storing, and
distributing biological samples should be included in the application.
Partnerships with other units at the institution that support these types of
activities should be described.

As for all cores, the application should include a
description of the types of research projects and/or clinical trials that use
or plan to use the core. Include specific examples and the likely benefits to
other research activities. If applicable, summarize activities carried out
during an earlier performance period for the teams or a center entity.

For renewals, summarize activities carried out during
the preceding performance period that demonstrate the level of success in
reaching previously stated goals.

Letters
of Support: Include letters of support where appropriate to
demonstrate collaborations, access to resources, institutional commitment, etc.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Integrative
Health Sciences Facility Core)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

Facility Cores

When preparing your application in ASSIST, use Component
Type ‘Core’.

A central function and process of the EHS CC grant is through
support of Facility Cores which are designed to furnish groups of EHS CC
investigators with technologies, services, or instrumentation that will enhance
the research in progress, consolidate manpower effort, and contribute to cost
effectiveness. At least three investigators with independently funded projects
and demonstrated need for such a core or service form the minimum required
research base to establish a core facility. The minimum set of users does not
in itself provide sufficient justification for establishment of a Facility
Core. The EHS CC must have at least two facility cores, one of which must be
the Integrative Health Sciences Facility Core, which is described above.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Facility Cores)

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in
the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

Budget (Facility Cores)

Budget forms appropriate for the specific component
will be included in the application package.

For a list of allowed or restricted budget items,
please see the Budget section under Administrative Core above.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Facility
Cores)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims: State the specific aims of the Facility Core.

Research
Strategy: Describe the Facility Core. Facility cores should
draw on EHS CC research needs, including, but not limited to: animal use and
transgenic, imaging, tissue culture, pathology support, biostatistics and
statistical support, oligonucleotide synthesis, analytical chemistry,
proteomics, bioinformatics, exposure assessment, and handling of human tissue specimens.
Establishment and continued support for Facility Cores by a EHS CC application
must be justified on the basis of use by independently funded EHS CC
investigators. The utilization of Facility Cores by pilot projects is
encouraged.

Facility Cores for the EHS CC should be unique and not
duplicate services or facilities that already exist at the parent or
collaborating institutions or can be purchased commercially. University-wide
facility cores providing services in areas relevant to environmental health
research have become more widely available at many research centers. EHS CCs
should utilize existing facility cores where appropriate and describe in the
application how members of the EHS CC would receive priority access, favorable
cost arrangements, and training on unique technologies. If facilities within a
university-wide facility are not sufficient to meet the needs of the EHS CC,
then the applicant is to provide information on the existing facilities and on
how the Center and greater university facility plan to partner. Proposed Center
Facility Cores that appear to replicate services already available at the
applicant institution will not be allowed without extensive justification.
Facility Cores should not duplicate services that can be purchased in the
private sector at prices below university-derived costs.

The application must provide the total operating
budget for each Facility Core together with the percentage of support requested
from the Center Grant. User logs or similar information used to complete the
on-line form should be maintained and made available on request to the NIEHS in
order to validate the extent of use and degree of sharing. In the case of new
proposed Centers or new Facility Cores within an existing Center, similar information
regarding anticipated use of the Cores should be provided. Define the use or
expected use of the Facility Core by Center members and/or projects in terms of
Low, Medium, or High (on a scale of 1-3).

Each Facility Core must have a designated leader who
will be responsible for core activities. The application should explain the
organization and proposed mode of operation of each core. It should include a
plan for prioritizing investigator use of the core as well as a definition of
qualified proposed and potential users. This definition need not be too narrow,
since limited use of a core might be an enticement to established investigators
in other fields to lend their expertise to the field of environmental health.
The use of the Facility Core for training purposes is encouraged and, if so
planned, a description of the extent of and approach to this training should be
included.

Although Facility Cores are meant to provide services
for Center members, they also play an important role in developing new methodologies,
adapting instrumentation for Center needs, and educating Center members of the
value and utility of services and methods. Funds can be designated to support
these aspects of the Facility Cores and discussion of how these activities will
be performed should be included in the application.

For renewals, summarize activities carried out during
the preceding performance period that demonstrate the level of success in
reaching previously stated goals.

Letters
of Support: Include letters of support where appropriate to
demonstrate collaborations, access to resources, institutional commitment, etc.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Facility Cores)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Facility Cores)

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

Community Outreach and Engagement Core

When preparing your application in ASSIST, use Component
Type ‘Core.’

The EHS CC occupies a unique position to develop and sustain
community outreach and engagement activities through their COEC. Programs
developed by COECs will lead the field of environmental health outreach and
engagement at the local and national level. To ensure responsiveness and
relevance to community (broadly defined) needs, the COEC promotes
multi-directional communication among the EHS CC and its stated target
audiences on issues of prevention, environmental health literacy, and
environmental public health.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of Core Lead’ and provide a valid eRA Commons ID in
the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

Budget (Community Outreach and
Engagement Core)

Budget forms appropriate for the specific component
will be included in the application package.

For a list of allowed or restricted budget items,
please see the Budget section under Administrative Core above.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Community
Outreach and Engagement Core)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims: State the aims for the Community Outreach and Engagement
Core (COEC). The EHS CC occupies a unique position to develop and sustain
community outreach and engagement activities through their COEC. Programs
developed by COECs will lead the field of environmental health outreach and
engagement at the local and national level. To ensure responsiveness and
relevance to community (broadly defined) needs, the COEC promotes
multi-directional communication among the EHS CC and its stated target
audiences on issues of prevention, environmental health literacy, and
environmental public health.

Research
Strategy: Describe the COEC’s vision and objective to conduct
each of the following three critical functions.

1. Translate and disseminate EHS CC research results
into environmental public health knowledge for identified audience(s). COECs
develop and implement appropriate outreach and engagement programs to increase
awareness and understanding of environmental health research being conducted at
the EHS CC.

2. Communicate audience issues, needs, and concerns
to EHS CC members. In working with community-based organizations, disease
advocacy groups, and other local, state, or regional partners to enhance
dialogue, as well as fostering interactions with Center members on
environmental health issues the informs and guides CCTEH members in developing
appropriate research activities that address the expressed needs.

3. Advance the field of community engagement.
Evaluate outreach models, disseminate results at local and national levels, and
promote models for national implementation.

The objectives, activities, and products outlined in
the strategy must be aligned and integrated with the research strengths and
focus of the EHS CC.

COECs must:

Identify
one or more audience(s) most appropriate to the mission of the EHS CC. For the
purposes of the EHS CC Program, there are three target audiences of interest:
Community, Policy-makers, and Public Health and/or Health Care Professionals.

Establish
a Stakeholder Advisory Board (SAB) to facilitate and strengthen multi-directional
interaction between the EHS CC and partners.

Possess
the appropriate expertise for the identified target audience and outlined
activities. COECs should be directed by staff trained in public health,
outreach and education, and/or other relevant disciplines at a Master’s or
Doctoral level.

As part of their plan on how they will carry-out
these three key functions, COECs should:

state clear and measurable objectives;

demonstrate
alignment to research strength and focus of the Center;

identify
existing and future partners;

prioritize
short, mid, and long-term activities to be implemented;

list and
describe expected products;

identify
specific environmental problems;

outline
how they are capable of responding to new issues;

state
anticipated impacts and their significance for environmental public health; and

COECs are
not expected to conduct community-based participatory research (CBPR), as it is
not their intended goal. COECs may choose to align their vision and goals to
the principles of CBPR. As described in the Principles of Community Engagement,
NIEHS seeks more collaborative efforts. http://www.atsdr.cdc.gov/communityengagement/pce_what.html

Collaborations
among COECs in EHS CCs are desirable. Support of collaborations can be from
NIEHS/NIH or other agencies and foundations.

COECs are
encouraged to contact NIEHS staff within the Division of Extramural Research
and the Office of Communication and Public Liaison in developing printed and
audiovisual educational materials. These outreach activities must be identified
as programs supported by the EHS CC.

Although COEC is not intended to include human
subject research, epidemiology, clinical trials, clinical services delivery, or
community-engaged research, the Core may be useful in establishing a
relationship with a community-based organization that could form the foundation
of a research grant application. In such cases, COEC proposals may be
considered for pilot project funding. COEC activities should not go beyond
public and community education concerning environmental disease risk and/or
hazard exposure recognition, as the COEC is not intended to give medical,
legal, political, social, or economic advice.

For renewals, summarize activities
carried out during the preceding performance period that demonstrate the level
of success in reaching previously stated goals. Clearly delineate and report
the specific activities, products, integration with other Center activities,
etc. that document the accomplishments of the COEC.

Letters
of Support: Include letters of support where appropriate to
demonstrate collaborations, access to resources, institutional commitment, etc.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Community
Outreach and Engagement Core)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

Other
Attachments: Please title an attachment "Pilot
Projects" and list all Pilot Projects supported all or in part by the EHS
CC. Include the years funded, awardee, amount of funds for the pilot, title,
publications derived from support, and resulting grants funded (including
annual direct costs, grant number, and funding agency). Table E is provided
for applicant assistance with this requirement (see http://www.niehs.nih.gov/research/supported/dert/programs/core/guidelines/index.cfm).

Project /Performance Site Location(s)
(Pilot Project Program)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Pilot Project Program)

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID
in the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

Budget (Pilot Project Program)

Budget forms appropriate for the specific component
will be included in the application package.

It is expected that about 25% of the annual direct
costs will be allocated to Pilot Project support, although greater amounts may
be requested with justification.

For a list of allowed or restricted budget items,
please see the Budget section under Administrative Core above. However,
considerable discretion is allowed for funding of pilot projects and reasonable
costs associated with research projects are permitted. Conference Travel to
present findings is not allowed. In addition, the Pilot Projects Program may include
a reasonable level of salary support for the Project Leader and other
participating staff.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Pilot
Project Program)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims: State the aims for the Pilot Project Program.

Research
Strategy: A Pilot Project Program is an integral part of the EHS
CCs. The Research Strategy for this section should include a plan to support
pilot studies for basic or clinical biomedical, epidemiological, educational,
or behavioral research. The description of a plan to solicit, review, and
administer pilot grants must be included and a separate budget, including the
total request for pilots, must be submitted. Criteria for review of pilot
studies must be developed and included in the application. The Pilot Project
Program should support short-term projects to explore the feasibility of new
areas of study which leads to collection of sufficient data to pursue support
through other funding mechanisms. Include a clear description of the process
designed to award and evaluate progress in pilot projects. Investigators are
encouraged to consult with NIEHS program staff for submission of new NIH
applications based on pilot project-supported data.

Pilot Projects are intended to:

(a) Provide initial support for new investigators to
establish new lines of research;

(b) Allow exploration of possible innovative new
directions representing a significant departure from ongoing funded research
for established investigators in environmental health sciences;

(c) Stimulate investigators from other areas of
endeavor to apply their expertise to environmental health research and
environmental medicine; and

(d) Foster opportunities that meet goals set out in
the EHS CC Plan. Pilot projects should strive to fill in gaps in research areas
relevant to the scientific focus of the EHS CC.

While Foreign Components are not acceptable in the EHS
CC, select pilot projects partly performed in a foreign country may be approved
by NIEHS after an award is made. The pilot project must demonstrate a highly
compelling justification both to the EHS CC through its selection process and
to NIEHS. All foreign pilot projects are subject to NIH and Federal regulations
and guidelines governing the approval of such activities and will be considered
case-by-case.

A renewal or re-submitted application should include:
historical overview of the Pilot Project Program during the last program
period; a description of the management of the program; and a listing of all pilot
projects which were supported during the last project period. The basis for
grant support resulting from pilot projects should be discussed briefly in the
application. For example, funds for preliminary data collection, use of Center
facilities, or guidance and/or collaborations dependent upon within the Center
could be cited as appropriate. Include the process for application review and
award and the measures of success, such as publications, subsequent funding,
and career advancement of the sponsored individuals.

Letters
of Support: Include letters of support where appropriate to
demonstrate collaborations, access to resources, institutional commitment, etc.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot
Project Program)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

Career Development Core

When preparing your application in ASSIST, use Component
Type ‘Career Dev Core.’ The Career Development Core activities can be
constituted as an independent Program or as part of the Administrative Core,
but please describe the activities in this section.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Career
Development Core)

Complete only the following fields:

Applicant
Information

Type of
Applicant (optional)

Descriptive
Title of Applicant’s Project

Proposed
Project Start/Ending Dates

PHS 398 Cover Page Supplement (Career
Development Core)

Enter Human Embryonic Stem Cells in each relevant
component.

Research & Related Other Project
Information (Career Development Core)

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID
in the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are working
in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

Budget (Career Development Core)

Budget forms appropriate for the specific component will
be included in the application package.

For a list of allowed or restricted budget items,
please see the Budget section under Administrative Core above. However,
considerable leniency is provided to Career Development candidates regarding
training and travel, as detailed below.

Direct costs for the sum of career development
activities should not exceed $150,000 annually. This figure does not include
salary for the EHS CC’s “New Investigator” or “Recruited Center Investigator”.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Career
Development Core)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is allowed for each component.

Specific
Aims: Present the aims for Career Development.

Research
Strategy: The EHS CC Program encourages clinical and basic
scientists with a broad range of skills to work together on a unified theme presenting
a rich environment for young investigators to be exposed to and develop skills.
To this end, a Career Development Program is required. Mid-level investigators
and scientists in other fields may also be attracted by opportunities in the
Center to focus their attention on issues in environmental health sciences and
human disease. Financial support can be provided for training and mentoring of
physician scientists to study environmental health issues that are relevant to
translational and clinical research or public health. In addition,
environmental health scientists can be supported to engage in activities which
increase their understanding of clinical research. Optimally, the Career
Development activity would assist new investigators in progressing to more
senior status and eventual NIEHS funding by enhancing their research skills and
knowledge in translational and clinical research.

Describe the target candidates, operation, and plans
for career development. The career development activities should be directed by
an investigator with strong mentoring credentials who will devote a defined
percent effort (0.5 months suggested). To facilitate mentoring and
multidisciplinary developmental activities, active involvement by senior
investigators within the EHS CC is strongly encouraged in an effort to match
mentors with candidates. The plan for career development activities will be
evaluated in terms of potential effectiveness in developing the skills and
research capabilities of investigators as reflected in the following required
elements of the application:

A
discussion of how mentoring and the professional development of the
investigators will be achieved, including their progression to a more
independent status.

A plan
for monitoring the progress of the career development of selected
investigators.

Examples
of planned scientific enrichment activities for selected investigators
including training experiences, mini-sabbaticals, special lectures, visiting
scientist symposia, seminars, workshops, and short courses both at the parent
institution or off-site.

In order
to increase diversity in the student and faculty populations and the
participation of individuals currently under-represented in the biomedical,
clinical, behavioral, and social sciences, applicants are encouraged to
designate new and recruited investigators from the following groups: women,
under-represented racial and ethnic groups; individuals with disabilities; and
individuals from socially, culturally, economically, or educationally
disadvantaged backgrounds that have inhibited their ability to pursue a career
in health-related research.

Assisting new investigators in attaining independent
status or established investigators in developing new promising areas of
expertise should be an objective of the Core activities. Sponsored participants
should be encouraged to apply for NIEHS sponsored Career Development Awards,
independent research grants, or other types of independent support. Contact
with NIEHS program staff is encouraged at an early stage in submission of new
applications.

The following activities are consistent with Career
Development in the EHS CC:

New
Investigator

Temporary salary support (up to 9 months effort) for
1 - 2 years and equipment may be provided in the application for a named New
Investigator in a specified area of research. The investigator can work in the
basic sciences, clinical research, or public health disciplines relevant to
environmental health. Former post-doctoral assistants and fellows are eligible
for this position.

The New Investigator
indicated in the application is eligible to compete for support for up to 2
years through the pilot project program. Subsequently recruited individuals are
to be named by the Center Director and submitted for approval to the EHS CC's
Internal or External Advisory Board, as appropriate.

Recruited
Center Investigators

The EHS CC grant may provide partial salary support
(up to 9 months effort) for not more than 2 years, technical support, and
equipment for independent investigators newly recruited from outside the
Center. This mechanism is intended to infuse Center research with novel
technologies and approaches by supporting independent investigators. The
recruit would be expected to bring new technologies or novel scientific areas
of expertise into the environmental health sciences arena that enhance the
Center’s research capabilities. Former graduate students and postdoctoral
fellows of Center members should not be considered for support unless, in
exceptional cases, it can be demonstrated that they have established
independent research careers and will provide critical expertise.

Specific
individuals to be awarded Recruited Center Investigator support need not be
identified in the application, but the amount budgeted for this purpose should
be declared, and, to the extent possible, the types of individuals sought and
their expected roles in the Center described.

For renewal applications, summarize activities
carried out during the preceding performance period that demonstrate the level
of success in reaching previously stated goals. Clearly delineate and report
the specific activities, products, publications, candidate selection and
training, integration with COEC activities, etc. that document the
accomplishments of this Center component.

Letters
of Support: Include letters of support where appropriate to
demonstrate collaborations, access to resources, institutional commitment, etc.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Career
Development Core)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential fieldof the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by the
National Institute of Environmental Health Sciences, NIH. Applications that are
incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to
notify the NIEHS Scientific Review Officer, Dr Bass by email at bass@niehs.nih.gov when the application
has been submitted. Please include the FOA number and title, PD/PI name, and
title of the application.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Are the EHS CC’s plans targeted toward building
research capacity? Will the plans, as proposed, attract investigators to the EHS
CC from within and outside environmental health sciences? Will the research
supported by the EHS CC likely contribute to understanding of environmental
health sciences and, ultimately, public health?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Does the Director or Facility Core leader demonstrate
the ability to provide scientific and administrative leadership and direction?
Does the application indicate that the Director has the authority to appoint
new members to the EHS CC and discontinue membership status, when appropriate?
Is the Deputy Director qualified to serve in the absence of the Director?

Innovation

Does the application challenge and seek to shift current
research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?Does the EHS CC demonstrate that it includes the skills,
technologies, and capacity to foster interdisciplinary, state-of-the-art, and
innovative research that would lead to important discoveries or major scientific
advances in the chosen areas of focus? Are the size and breadth of the research
grant base in the EHS CC directly relevant to environmental health sciences and
to the theme of the EHS CC, placing special emphasis on NIEHS-supported grants?
Does the EHS CC take advantage of the capability of its research base to
maximize scientific productivity, particularly through interdisciplinary
coordination and collaboration?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate
the following additional items while determining scientific and technical
merit, and in providing an overall impact score, but will not give separate
scores for these items.

Overall/Strategic Vision:

Does the
applicant articulate a clear and practical set of goals?

Are the
goals reasonable and attainable in consideration of the expertise, facilities,
and funds available?

Are the EHS
CC’s plans sufficient to promote multi-disciplinary studies and collaborations,
especially among basic scientists and clinical researchers?

Does the
Vision suggest and present plans to encourage collaboration, sharing of
resources within the EHS CC, and steps towards translational science and
dissemination?

Are the
results of following the path outlined in the Vision likely to lead to advances
in e.g., environmental health sciences or related fields, improved training of
early stage investigators, improved community engagement, and/or public health?

Institutional Org/Commitment:

Is the
level of institutional commitment appropriate and demonstrative of significant
support to the EHS CC?

Do the
presence, stature, and effectiveness of the NIEHS EHS CC represent an
established organizational component within the institution?

Administrative Core:

Is the
administrative structure designed for effective management of the EHS CC?

How well
does the EHS CC plan for initiating, continuing, and discontinuing individual
membership?

Is the
percent effort of the administrative staff of the EHS CC appropriate, in terms
of their qualifications and contributions to the specialized needs and conduct
of the EHS CC's research activities?

What are
the EHS CC’s plans for using the Internal Advisory Committee and External
Advisory Committee? Is the expertise of the advisory committees adequate?

Facility/Service Cores:

What is
the Core’s utility to the overall EHS CC and its membership?

How well
does the proposed Facility Core respond to the needs of the EHS CC membership
and the chosen scientific or outreach focus of the application? Do the plans
suggest outstanding quality?

Are plans
presented for quality control and to provide the services or materials within
reasonable timeframes?

Are the
Facility Cores and their services and materials timely and at the frontier of
technology appropriate for the research the EHS CC plans to support?

Is the
Facility Core cost-effective?

What are
the overall qualifications of the personnel involved?

Integrative Health Sciences Facility
Core:

Will the
services offered for technologies foster the integration of basic science,
public health research, including epidemiology and intervention studies, and
patient-oriented clinical research?

Is the
research support adequate to improve early detection, prevention, and/or
therapy for environmentally–related disorders?

How well
do the EHS CC and community based organizations support partnerships between
researchers that will impact on the conduct of clinical and public health
research?

Community Outreach and Engagement
Core (COEC):

(a) Vision and Objective

Is the
COEC a logical outgrowth of the EHS CC theme?

Will the
COEC lead to a mutually-beneficial, bidirectional relationship between the
academic institution and the community?

Are
objectives for COEC clear and measurable? Do they prioritize short, mid and
long-term activities? Are evaluation plans defined to measure the impact of
core activities? If so, are the evaluation plans appropriate?

(b) Translating research information into
environmental public health knowledge:

Are
outreach and educational engagement programs proposed to increase awareness and
understanding of environmental health research being conducted at the EHS CC?

How
appropriate is the identified target audience? With respect to the COEC’s
defined target audience, are the specific plans, activities, and coordination
for the proposed COEC, appropriate?

What is
the role of the Core in the activities in the EHS CC? Is adequate integration
proposed?

Is the
past and/or projected use of the Core sufficient to warrant its establishment
or continuance? Is the use of the Core balanced and broadly based as opposed
to being used by a few individuals?

(c) Ensuring EHS CC understanding of community and
other stakeholder needs

Is the
composition of the Stakeholder Advisory Board (SAB) adequate and what is the contribution
of this group to administrative decisions?

Other
than the SAB, are the specific plans appropriate to increasing EHS CC awareness
of community concerns?

Do the
plans adequately describe a process for maintaining transparent communications
between the identified audience and the academic partners throughout the entire
process of the activity?

Does the
plan address methods of building and sustaining community partnerships and
community participation?

(d) Leadership and staff expertise

Is the
COEC Director qualified for the position? Does he or she demonstrate expertise
in public health, outreach and education, health communication, or other
relevant disciplines at the Master’s or Doctoral level?

Does the
investigator provide previous experience/evidence for conducting community
engagement activities/projects?

Does the
proposed staff possess suitable expertise to fulfill the stated objectives of
the COEC?

Do the
plans enhance the likelihood of success?

Pilot Project Program:

How feasible
and practical are the EHS CC plans to review and distribute funds for pilots?

Does the EHS
CC plan to use pilot project funds in a manner that encourages innovative ideas
of importance to environmental health sciences?

Will the EHS
CC use the Pilot Project Program in order to fill gaps in research areas
relevant to the scientific focus of the EHS CC?

Are there
adequate plans to use pilot projects to support early stage investigators to
supplement career development aims?

Career Development for Environmental
Health Investigators:

Are the
career development strategies employed by the EHS CC for future research
leaders in environmental health sciences, environmental medicine, and public
health appropriate?

How well
does the EHS CC plan and carry out recruiting and training of new
investigators?

Is the EHS
CC‘s plan for cross-training junior and established investigators sufficient to
train researchers to learn current and necessary techniques that are absent
from their research programs?

Does the EHS
CC’s plan provide high quality mentoring of junior investigators so as to
foster their research careers? Is a mentoring plan proposed, and if so, is the
plan adequate? Are the EHS CC’s plans appropriate and likely to be effective
in assisting the progression and development of new and established
investigators in environmental health sciences?

Has the EHS
CC established itself as a recognizable entity in the fields of environmental
health sciences and environmental medicine and public health?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the progress
made in the last funding period. The following questions will be addressed:

Are the
overall quality and productivity of the Center members currently appropriate, especially
as they relate to the interactive, collaborative research opportunities in
basic, applied, and clinical research targeted by the Center?

Is there
evidence that the Center stimulates and increases the productivity of Center
members and supports novel approaches to environmental health science
research? Has the Center made major progress and achievements since its last
competitive renewal?

Have
there been any changes in the environmental health sciences research
orientation of the Center? If yes, what progress and opportunities have these
changes presented to Center members?

What
specific resources provided to the Center by the institution, such as
personnel, appropriate facilities, financial support, and other forms of
support will assure the success of the Center?

What were
the Center’s major accomplishments in the preceding project period and how did
they build upon its successes? Has the Center been successful in translating
basic science advances to the bedside, to public health, or to prevention or
from the applied areas back to the laboratory for refinement and improved
understanding of mechanisms? Are there adequate plans for enhancing these
transitions in the next project period?

Specifically, for Leadership and Expertise, both
overall in the Center and also in the COEC, reviewers will address the
following:

Is there
evidence that significant discoveries or major accomplishments have occurred
since the last review?

Is there
evidence of the effectiveness of the Center in developing novel technologies
and building upon research opportunities?

What is
the past performance of each senior leader in overseeing the planning,
integration, and coordination of research involved in the Center?

Specifically, for Pilot Projects reviewers will
address the following:

How well did
the Center review and distribute funds for the pilot projects?

Were pilot
project funds used in a manner that encourages innovative ideas of importance
to environmental health sciences?

Did the
Center use the Pilot Project Program to fill gaps in research areas relevant to
the scientific focus of the Center?

Have
pilot project funds been used to stimulate scientifically productive
interactions and collaborations?

Specifically, for Career Development reviewers will
address the following:

Has the
Career Development Program been successful in attracting promising candidates?

Are the
provided examples of training appropriate and practical for modern science and
career progression? Are the offered mentoring and skills appropriate for
cutting edge environmental health sciences?

Have the
candidates demonstrated appropriate upward progression in academic or
commercial sectors? Are reasonable levels of such progression provided, such as
publications in reputable journals, senior authorship, grant funding,
increasing obligations from the Institution, and promotion?

Specifically for Community Outreach and Engagement
Cores reviewers will address the following:

What is the past progress
of the Center in the development of an effective COEC? What impact has the
Center had on the target audience? What impact has the COEC had on the Center?
What types of educational and outreach materials have been created as part of
the COEC? Are they relevant to the science of the Center?

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider
each of the following items, but will not give scores for these items, and
should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor possession
use and transfer of Select Agent(s), and 4) plans for appropriate biosafety,
biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National
Institute of Environmental Health Sciences, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Environmental Health Sciences Council. The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The awardee institution will provide NIH with specific plans for
data and safety monitoring, and will notify the IRB and NIH of serious adverse
events and unanticipated problems, consistent with NIH DSMP
policies.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.